Aquastat SFR 2S0706Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10859809005009), received between Dec 16, 2016 and Mar 13, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K120836); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AQUABILITI FLUSH SYRINGE (2S0706) WAS USED VIA THE PATIENT'S ACCESS PORT. THE PATIENT IMMEDIATELY INDICATED THEY WERE NOT FEELING WELL. THE TENDING CLINICIANS THEN NOTED THAT IT APPEARED AS THOUGH THE PATIENT WAS HAVING AN ALLERGIC REACTION, AS HIS/HER SKIN APPEARED RED IN COLOR. FROM THE INFORMATION PROVIDED: PER NURSING REPORT: LAST WEDNESDAY FEBRUARY 8, ABOVE PATIENT WAS SCHEDULED FOR CHEMOTHERAPY TREATMENT. RIGHT AFTER THE NURSE ACCESSED THE PORT FOLLOWING THE HOSPITAL PROTOCOL USING THE STERILE NORMAL SALINE FLUSH, THE PATIENT STATED WAS NOT FEELING WELL AND VITAL SIGNS BECAME UNSTABLE. APP CAME TO ASSESS THE PATIENT AND NOTICED AN ALLERGIC REACTION ON HER ARMS-HIVES/REDNESS - AND SWOLLEN LIPS. AFTER PATIENT WAS STABILIZED, SHE WAS TRANSFERRED VIA 911 TO THE ER.

  Patient problems: Administration Site Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 16533987 ↗
• MalfunctionJul 24, 2017Product Quality Problem; Material Deformation; Packaging Problem; Product Quality Problem; Material Deformation; Packaging Problem

  CUSTOMER REPORTED PRODUCT PACKAGING DEFORMATIONS ON THE SYRINGE'S POUCH SEALS.

  Patient problems: No Patient Involvement

  MAUDE report 6737822 ↗
• MalfunctionJul 20, 2017Product Quality Problem; Material Deformation; Packaging Problem; Product Quality Problem; Material Deformation; Packaging Problem

  CUSTOMER REPORTED PRODUCT'S STERILE FIELD READY FLUSH SYRINGE POUCH CONTAINED DEFORMATIONS ON THE SEALED PORTION OF THE POUCH.

  Patient problems: No Patient Involvement

  MAUDE report 6730827 ↗
• MalfunctionJul 20, 2017Product Quality Problem; Material Deformation; Packaging Problem; Product Quality Problem; Material Deformation; Packaging Problem

  CUSTOMER REPORTED PRODUCT PACKAGING DEFORMATIONS ON THE SYRINGE'S STERILE FIELD READY POUCHES.

  Patient problems: No Patient Involvement

  MAUDE report 6730651 ↗
• MalfunctionJul 19, 2017Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  DURING AQL INSPECTION, CUSTOMER REPORTED 106 SYRINGES WERE FOUND WITH PARTICULATE MATTER CONTAINED WITHIN SYRINGE POUCHES.

  Patient problems: No Patient Involvement

  MAUDE report 6725899 ↗
• MalfunctionDec 16, 2016Unsealed Device Packaging; Device Packaging Compromised; Packaging Problem; Unsealed Device Packaging; Device Packaging Compromised; Packaging Problem

  DURING AQL INSPECTION, A SYRINGE SEAL WAS FOUND TO BE COMPROMISED. THE CUSTOMER (CONVIENENCE KIT MANUFACTURER) REJECTED THE LOT BASED ON THIS INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 6182764 ↗
• MalfunctionDec 16, 2016Unsealed Device Packaging; Device Packaging Compromised; Packaging Problem; Unsealed Device Packaging; Device Packaging Compromised; Packaging Problem

  (B)(4) ACCESS SYSTEMS' INCOMING INSPECTION FOUND ONE OF THE AQUABILITI STERILE FIELD READY PRODUCTS WITH AN OPEN POUCH. (B)(4) ACCESS SYSTEMS USES THE AQUABILITI'S 2S0706 PRODUCT AS A COMPONENT IN THE KITS THEY MARKET / DISTRIBUTE.

  Patient problems: No Patient Involvement

  MAUDE report 6180018 ↗
• MalfunctionDec 16, 2016Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  CUSTOMER REPORTED AN END USER DISCOVERED ONE OF AQUABILITI'S STERILE FIELD READY SYRINGE CONTAINED A FOREIGN OBJECT (HAIR) IN THE SALINE. THE SYRINGE WAS NOT UTILIZED FOR THE PATIENT'S TREATMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6180012 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120836. One submission often covers many models, so check the product and lot details in each record.

• Z-2476-2015 · Jul 2, 2015 · Terminated
  0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
• Z-1808-2015 · Feb 9, 2015 · Terminated
  T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.